validation package rev. e... · 13/7/2020 · • meets ista 3a, and ista 7e and iata pi 650...

Validation Package

17305 Daimler Street

Irvine, California 92614

Office 949.470.2300

[email protected]

MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020

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Created for customer use only

Proprietary and Confidential

For more information about the data, please contact Cryoport Quality directly at [email protected]


SPECIFICATIONS Standard Dry Vapor Shipper

(EXP6)

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Dynamic Holding Time: Up to 10 Days

Holding Temperature: -150°C or colder

Core Technology: Dry Vapor Liquid Nitrogen

Specimen Chamber: 3.1" (79mm) diameter

11.5" (292mm) depth

Storage Capacity: 75 of 1.8 & 2.0 ml vials

15 canes with 5 vial clips

75 cryovials, 2.0 ml

Weight: Dry 9.7 lbs./ 4.4 kg

Charged 18.3 lbs./ 8.3 kg

Domestic Dimensional: 21.07 lbs. / 9.56 kg

International Dimensional: 24.87 lbs. / 11.28 kg

Outer Box: 12" x 12" x 22"

(305 x 305 x 559mm)

IATA Rated for Category B

Up to 10-day dynamic holding time qualified under normal shipping conditions per shipment

Specimen Chamber


FEATURES Standard Dry Vapor Shipper

(EXP6)

• Flat bottom for improved handling and

package design

• Lockable vapor plug with aesthetically

appealing Cryoport Blue cap

• Integrated Thermocouple installation tube

• Cabosil fumed silica absorption material

• Streamlined thermocouple lead wire assembly

• Improvement in the average overall hold-time

performance

• Meets ISTA 3A, and ISTA 7E and IATA PI 650Returnable Package Construction

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Rollerboard


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SPECIFICATIONS Combo Dry Vapor Shipper

(CXCBO)

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Specimen Chamber: 2.8" (71mm) diameter

11.5" (292mm) depth

Storage Capacity: 75 of 1.8 & 2.0 ml vials

15 canes with 5 vial clips

75 cryovials, 2.0 ml

Combo Box

Top Accessory Tray: 7.25” x 10.5” x 2”May be used for paperwork, medical kits, etc.

Weight: Dry 15 lbs./ 6.8 kg

Charged 20 lbs./ 9.07 kg

Domestic Dimensional: 21.07 lbs./ 9.56 kg

International Dimensional: 24.87 lbs./ 11.28 kg

Outer Box: 12" x 12" x 24"

(305 x 305 x 584mm)


Up to 10-day dynamic holding time qualified under normal shipping conditions per shipment

Top

Accessory

Tray


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SPECIFICATIONS High Volume Dry Vapor Shipper

(CXHVO)

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Specimen Chamber : 8.5” (215.9 mm) diameter

12.75” (323.85 mm) depth

Storage Capacity: Five 5“x 5” x 2“ cryovial boxes

81 2.0 ml vials per box = 405 vials

Five 5.25” x 5.25“ x 2” cryovial boxes

100 2.0ml vials per box = 500 vials

Six Safepak® bags with 15 5-vial canes per bag

75 2.0ml vials per bag = 450 vials

One Safepak®XL bag (with optional Cryostrap®)

Dimensions of the 7.3” (185.42 mm) diameter

Internal Canister*: 8.6” (218.44 mm) depth*When using for Category A and B substances

Weight: Dry 50 lbs./ 22.7 kg

Charged 71 lbs./ 32.2 kg

Domestic Dimensional: 79.68 lbs. / 36.14 kg

International Dimensional: 94.01 lbs. / 42.64 kg

Outer Container: 22" (558.8 mm) diameter x 27" (685.8mm) tall


Up to 10-day dynamic holding time qualified under normal shipping conditions per shipment Specimen Chamber


FEATURES High Volume Dry Vapor Shipper

(CXHVO)

• Custom designed, light weight

aircraft grade aluminum

• Vapor plug

• Liquid Nitrogen retention media

• Cryogenic temperatures up to 10

days

• Large payload capacity

• Impervious to External Heat

7MKT-124 Rev. E DCN-760 Effective Date: 07/13/2020

The Sliderite™ pallet has two primary

modes that are controlled by the pedals on

either end of the pallet.

Pushing down on the RED pedal puts the

pallet into the stationary mode. In this

mode the pallet will not roll.

Pushing on the GREEN Pedal put the pallet

into the motion mode and allows the pallet

to be rolled about.

SPECIFICATIONS Sliderite® - High Volume

Shipper Palletized (SRHVO)

• The Sliderite® is a mobile pallet developed

to assure that the Cryoport High Volume

Shipper (CXHVO) remains in the upright

position.

• Maintaining this orientation assures that the

shippers validated temperature hold time

can be achieved.

• It also allows for easy mobility of the High

Volume Shipper.

• Outer Dimensions: 24” L x 32” W x 36” H

• Weight: Dry – 92 lbs. / 42 kg

Charged – 121 lbs / 55 kg


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Dynamic Holding Time: Up to 96 Hours

Holding Temperature: 2°C - 8°C

Core Technology: Phase Change

Specimen Chamber: 8.9” x 8.9” x 8.9”

Weight: 25 lbs./ 11.34 kg

Dimensional Weight 21 lbs./ 9.52 kg

Outer Box: 16" x 14" x 15"

(407 x 356 x 381mm)


Up to 96 hour dynamic holding time qualified under normal

shipping conditions per shipment.

SPECIFICATIONS C3™ 2 - 8°C Shipper


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Dynamic Summer

Profile Holding Time: Up to 96 Hours

Dynamic Winter

Profile Holding Time: Up to 72 hours

Holding Temperature: 15°C - 2°5C

Core Technology: Phase Change

Specimen Chamber: 8.9” x 8.9” x 8.9”

Weight: 25 lbs./ 11.34 kg

Dimensional Weight 21 lbs./ 9.52 kg

Outer Box: 16" x 14" x 15"

(407 x 356 x 381mm)


Up to 96 hour dynamic summer profile holding time qualified under

normal shipping conditions per shipment.

Up to 72 hour dynamic winter profile holding time qualified under

normal shipping conditions per shipment.

SPECIFICATIONS C3™ CRT Shipper


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SPECIFICATIONS Data Logger and Data Station

Two Channel USB Temperature Data Logger

Channel 1 Measures Ambient Temperature

Channel 2 Measures Internal Temperature

Manufacturer: Onset Computing

Make: Hobo

Model: U12-014

Calibration Schedule: Annually by third party (NIST traceable

standards)

Standard Sampling Frequency: 5 minutes

The Cryoport Data Station allows for onsite download of the Data

Logger Temperature Tracking Report


SPECIFICATIONS Smartpak II®

Condition Monitoring System

Provides real time cellular tracking of location when used in conjunction with the Live View™ service feature (SRV-LIV)

Monitors and also measures the following:

• Temperature

• Orientation

• Shock

• Pressure

• Humidity

• Light

• Battery Life

Size: 5.31” x 2.09” x .55”

Operating Temperature: -20° C to +65° C / -4° F to +140° F

Temperature Measurement Range: -212° C to +100° C

Live View™


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ACCESSORIES

Cryostrap® Material: High-density polyethylene (HDPE)

Dimensions: 3” l x 36.127” h

Holds: 5’ x 5” Cryovial Boxes

Up to 9 Blood Cassettes

Canes Material: Aluminum

Dimensions: .5” diameter x 11.25” tall (12.7 x 285.75 mm)

Storage Capacity: Five 2.0 ml cryovials per cane

Canisters Material: Aluminum

Dimensions: 2.5” diameter x 12” tall

Storage Capacity: 15 Cryocanes with vials


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ACCESSORIES (continued)

Safepak® Material: Tyvek – 1073B (medical grade)

Tyvek Bags Dimensions: 5“ l x 23.625” h

(127 x 600 mm)

Safepak®XL Material: Tyvek – 1073B (medical grade)

Tyvek Bags Dimensions: 6.5" l x 5" w x 23.125" h

(165.1 x 127 x 587.4 mm)

Storage Capacity: 1 Box Rack

The Tyvek bags are used for infectious substances and pass IATA

testing for class 6.2 substances. IATA Rated for Category B.

Labels: UN3373, UN2814, UN2900, UN3245, No Not X-Ray,

Exempt Human Substance, Exempt Animal

Substance, Tamper Resistant Serialized Labels.

Miscellaneous: Canisters, Racks, Lifters, Goblets


VALIDATION CXCBO Validation Studies

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Infectious Substance Shipping

Regulation/Guidelines: IATA Packaging Instruction 650 (Class 6 – Toxic and Infectious Substances UN 3373)

Testing/Validation Study: Infectious Substance Category B Design Qualification

Conducted by Ten-E Testing Labs

Passed the standards of the DEPARTMENT OF TRANSPORTATION’S TITLE 49 CFR; Category B Infectious

Substance, Section 173.199. This package is also certified under IMDG, and the UN Recommendations on the

Transport of Dangerous Goods.

Reports available upon request

Holding Time Performance

Regulation/Guidelines: ISTA 7E-2010 (Heat) and ISTA 3A-2008 (Thermal and Performance Validation)

Testing/Validation Study: EXP-5 Hold Time Study and Qualification for EXP-5 CXCBO

Protocol:

OQ – Three min loads and three max loads tested in an environmental chamber using ISTA 7E Heat

profiles for 245 hours. ISTA 3A Drop Test Three min and three max loads tested to ISTA 3A Drop Test

specifications.

PQ – Three min loads and three max loads tested with Global Shipping Study.

Results:

OQ – Meets requirements

PQ – Meets minimum 10 day requirement

Validation study available for review during an onsite audit.


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VALIDATION EXP6 Validation Studies










Regulation/Guidelines: ISTA 7E-2010 (Heat) and ISTA 3A-2008 (Thermal and Performance Validation)

Testing/Validation Study: EXP-6 Hold Time Study and Qualification for EXP-6 Standard Shipper

Protocol:


profiles for 245 hours. ISTA 3A Drop Test Three min and three max loads tested to ISTA 3A Drop Test

specifications.


Results:


PQ – Meets minimum 10 day requirement



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VALIDATION CXHVO Validation Studies


Regulation/Guidelines: IATA Packaging Instruction 620 (Class 6 – Toxic and Infectious Substances UN 2814 and UN 2900)

IATA Packaging Instruction 650 (Class 6 – Toxic and Infectious Substances UN 3373)

Testing/Validation Study: 1H2 Infectious Substance Category A Design Qualification

Conducted by Ten-E Testing Labs for Chart Industries

Resulting UN Marking for EXP5 1H2 / Class 6.2 / ** / USA / +AA7309



Regulation/Guidelines: ISTA 7E and 7D (Thermal Performance Validation)

Testing/Validation Study: Cryoport High Volume Dry Vapor Shipper Validation Package

Prepared by MJ Consulting

Conducted by WestPak, Inc.

Protocol:


profiles for 245 hours

PQ- ISTA 3A Drop Test Three min and three max loads tested to ISTA 3A Drop Test specifications, 17

drops from 12 to 24 inches each package.

TQV – Three min loads and three max loads shipped using standard carrier to determine holding time

Results:

OQ – Passed 315 Hours

PQ – Passed

TQV – Passed 334 Hours



VALIDATION C3™ 2-8°C Validation Studies

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* For blood bags only


Regulation/Guidelines: ISTA 7E-2010 and ISTA 3A-2008 (Thermal and Performance Validation)

Testing/Validation Study: C3™ Hold Time Study and Qualification for C3™

Protocol:

OQ – Three min loads and three max loads tested in an environmental chamber using ISTA 7E

Summer & Winter profiles for 245 hours. ISTA 3A Drop Test Three min and three max loads tested to

ISTA 3A Drop Test specifications.


Results:


PQ – Meets minimum 96 Hour requirement



VALIDATION C3™ CRT Validation Studies

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* For blood bags only


Regulation/Guidelines: ISTA 7E-2010 and ISTA 3A-2008 (Thermal and Performance Validation)

Testing/Validation Study: C3™ Hold Time Study and Qualification for C3™

Protocol:

OQ – Three min loads and three max loads tested in an environmental chamber using ISTA 7E

Summer & Winter profiles for 245 hours. ISTA 3A Drop Test Three min and three max loads tested to

ISTA 3A Drop Test specifications.


Results:


PQ – Meets minimum 96 Hour requirement (Summer Profile)

– Meets minimum 72 Hour requirement (Winter Profile)



validation package rev. e... · 13/7/2020 · • meets ista 3a, and ista 7e and iata pi 650...

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